WO2016107057A1

WO2016107057A1 - Fully-automatic immunofluorescence quantitative analysis device and detection method

Info

Publication number: WO2016107057A1
Application number: PCT/CN2015/079758
Authority: WO
Inventors: 苏恩本; 陈维森; 尹凌志; 王林; 李靖; 金晶
Original assignee: 基蛋生物科技股份有限公司
Priority date: 2014-12-29
Filing date: 2015-05-26
Publication date: 2016-07-07
Also published as: US20170082616A1; CN104535782A; SG11201609288YA; US10338064B2; CN104535782B

Abstract

The present invention belongs to the field of immunofluorescence quantity analysis and detection, and disclosed are a fully-automatic immunofluorescence quantitative analysis device and detection method. The immunity quantitative analysis device comprises: a support baseplate (1), a reagent strip storage and automatic loading module (3), a reaction disc module (4), a detection module (5), a sample module (6), a sample adding module (7), a washing module (8) and a control system, the reagent strip storage and automatic loading module (3), the reaction disc module (4), the detection module (5), the sample module (6), the sample adding module (7), the washing module (8) being sequentially arranged on the support baseplate (1). The reagent strip storage and automatic loading module (3) provide a reagent strip to the reaction disc module (4), and the sample adding module (7) adds the sample on the sample module (6) to the reaction disc module (4) and performs a reaction, and after the reaction is complete enters the detection module (5) to complete the detection. The present invention addresses the problem in which it is difficult to automate an external diagnostic product, reducing human error and improving test accuracy, and thereby improving detection efficiency.

Description

Automatic fluorescent immunological quantitative analysis device and detection method

Technical field

The invention belongs to the field of quantitative fluorescence immunoassay detection, and particularly relates to a fully automatic fluorescence immunoassay method and device.

Background technique

POCT, point-of-care testing is a sub-segment of in vitro diagnostic equipment (IVD), which is an on-site sampling and immediate analysis, eliminating the complicated procedures of specimens in laboratory tests and quickly obtaining test results.

In the quantitative detection of fluorescent immunoassay, most of the diagnostic instruments on the market are semi-automatic testing instruments. For example, the existing fluorescent immunochromatography analyzer GP1100 of Nanjing Basic Egg Biotechnology Co., Ltd. is a semi-automatic testing instrument, and its machine structure is only Including an optical path system and electronic display system for quantitative inspection, the loading and chromatography processes are done manually outside the machine; in use, first of all, because semi-automatic instruments are used for outdoor loading, for some temperatures are very high. The product inspection is very unfavorable; secondly, because manual sampling and sample loading steps are required, and then quantitative analysis by the instrument, the test error caused by manual intervention is increased, the immunochromatography layering time, the sampling accuracy, etc. are not Accurate, slow test speed, manual sample loading is easy to cause biological pollution; finally, most of the existing small detection instruments can only load one sample at a time, and then add another sample to the end after the test is completed. This has caused the following disadvantages: there must be a special manual duty, repeated loading of samples, manual intervention to cause biological pollution, and the detection personnel can not leave to carry out other testing work; in addition, one test at a time, low efficiency, delay diagnosis; Outdoor loading is not suitable for product testing with high temperature requirements.

Summary of the invention

In order to overcome the deficiencies of the prior art, the present invention discloses a fully automatic fluorescent immunological quantitative analysis device and a detection method thereof, which can repeatedly perform the fluorescence immunological quantitative detection work continuously, and has high sensitivity, simple operation and high repeatability.

The technical scheme adopted by the invention is as follows: a fully automatic fluorescent immunological quantitative analysis device, comprising a support bottom plate, a reagent strip storage and automatic loading module, a reaction disk module, a detection module, a sample module, a sample loading module, a washing module and a control system The reagent strip storage and automatic loading module, the reaction disk module, the detecting module, the sample module, the loading module, and the washing module are sequentially arranged on the supporting bottom plate, and the reagent strip is stored The storage and automatic loading module provides a reagent strip for the reaction disk module, and the sample loading module adds the sample in the sample module to the reaction disk module for reaction, and after completing the reaction, enters the detection module to complete the detection.

The loading module comprises an XYZ moving robot arm, a disposable tip picker and a syringe pump; the XYZ moving robot arm comprises an X arm, a Y arm and a Z arm, and the X arm is horizontally arranged along the sample module and the reaction disk module; the Y arm Located in the upper part of the sample module, it is vertically connected to the X arm and can slide on the X arm. The Z arm is vertically fixed in the sliding groove of the Y arm. It can be moved back and forth along the Y arm, and the disposable tip picker is installed at the bottom of the Z arm. . The stepper motor assembly is connected to the XYZ arm, and the control system controls the stepping motor assembly to control the sliding of the Y and Z arms, so that the disposable tip picker can move up and down and left and right in the sample module and the reaction disk module area.

The sample module comprises a disposable tip box, a mixing box, a diluent tank, a sample unit, a tip collection box and a sample module box, wherein the sample unit and the diluent tank are located on the bottom plate of the sample module box, and the bottom plate is provided with The track, the sample unit and the bottom of the dilution tank are arranged with the card slot matched with the track, the sample unit and the diluent tank slide back and forth on the floor track; the platform of the sample module box is arranged on the side, the lower part of the platform is separated, the suction head is recycled, and the disposable The tip box and the mixing box are discharged on the platform, and the part of the suction box of the suction head passes through the platform, and on the platform, part of the space is in the lower part of the platform, the top of the suction box is provided with a recovery port, and the bottom end is not sealed, sucking The head enters the recovery port and falls directly onto the bottom plate. The disposable tip box and the mixing box are supported by the support frame.

The sample module box is arranged in a drawer shape, and has baffles on the left and right sides. The outer side of the baffle has a pulley, which can slide back and forth along the outer slide rails, and a front end of the baffle has a fixed latch for fixing the drawer.

The reaction disk module is a disc-shaped device, the disc edge fixed the reagent strip slot, the slot mouth and the reagent strip storage and the auto-loading module correspond to the reagent strip exit position, loading the reagent strip; the reaction disc will take the reagent strip The sample loading operation is completed at the position corresponding to the loading module; the reaction tray takes the reagent strip to the position corresponding to the detecting module to complete the detecting operation.

The reaction disk is connected to the first motor, and the first motor drives the first synchronous wheel and the first synchronous belt to drive the reaction disk to rotate; the reaction plate reagent strip slot is 2N or 2N+1, N≥1, reagent strip The slots are preferably 16-20, and more preferably the reagent strip slots are 16.

The reagent strip storage and automatic loading module comprises a reagent strip storage box, a storage box bracket and an automatic loading component, the storage box bracket is fixed on the support bottom plate, and the reagent strip storage box is fixed on the storage box bracket by a buckle; the automatic loading component is The second motor, the second synchronous wheel, the second synchronous belt and the elastic hanging rod are formed, and the control system controls the second motor to drive, and drives the second synchronous wheel, the second synchronous belt, and the elastic hanging rod to move. Said A reagent strip slot is disposed in the reaction plate module, and a gap is formed in the middle of the lower bottom surface, and the notch allows the elastic hanging rod to send the reagent strip into the reagent strip slot. The elastic hanging rod is a rod, which is located under the reaction strip reagent strip slot, and can reciprocate under the reaction tray and the storage box along the straight line of the slot, and the front end rod portion has a resilient hook with a pressing force. When working, it enters under the reagent strip, and the hook is pressed down by the reagent strip until it enters the groove below the reagent strip to recover. The movement moves back from the storage box to the reagent strip slot of the reaction tray, and the hook is re-entered when exiting. Press down to exit the reagent strip groove.

The reagent strip storage box comprises a box body and a lid portion, the box body and the lid are sealed; the reagent strip storage box has a reagent strip descending rail; the reagent strip storage box has a notch at the bottom thereof, and the reagent strip storage box side is adjacent to the strip The bottom end of the notch has a sealing elastic piece; the notch extends from the bottom end side of the reagent strip storage box to the other side, and the extending length thereof may be from a notch corresponding to the reagent strip to the other side of the bottom end, The sealing shrapnel can only be bounced outside the reagent strip storage box.

There are 1-3 reagent strip storage and automatic loading device modules.

A desiccant receptacle for placing a desiccant is placed on the wall of the reagent strip storage case.

The reagent strip descending rail may be a rail attached to the inner wall of the reagent strip storage box, or a rail suspended from the top, and the distance between the reagent strip descending rail and the bottom end of the reagent strip storage box is 1-2 reagent strips. Between thicknesses.

A sensor can be placed on the reagent strip storage box holder assembly, and the number of remaining reagent strips can be counted by the sensor.

The detecting module is disposed on the supporting bottom plate and located at the periphery of the reaction turntable so that the reagent strip in the reaction tray can be detected under the rotation. The detection module includes an optical detection device, and the reagent strip in the reaction tray is rotated to the detection device to complete the fluorescence detection.

The bottom of the detecting module is provided with an elastic hanging rod. After the detecting module completes the detection of the reagent strip, the elastic hanging rod under the detecting module pushes the reagent strip out of the reaction tray and enters below the detecting device. After the next reagent strip has been tested, the previous reagent strip is pushed out of the device of the present embodiment by the next reagent strip, and the next reagent strip remains below the detection device. The elastic hanger at the bottom of the module is the same as the flexible hanger mechanism below the reagent strip slot of the reaction tray.

The washing module comprises a washing needle tank, a waste liquid bottle and a washing liquid bottle, and a pipe in the washing needle tank is connected with the waste liquid bottle and the washing liquid bottle. After the sample is added, the disposable tip picker moves to the needle washing tank, and the washing liquid bottle washes the disposable tip picker, and the waste liquid flows into the waste liquid bottle through the pipeline.

Another object of the present invention is to provide a method for detecting a fully automated fluorescent immunoassay comprising the following steps:

Step 1: The reagent strip storage and automatic loading module loads the reagent strip into the reagent strip slot in the reaction tray;

Step 2: The reaction tray starts to rotate, and the reagent strip in the first position enters the sample loading area and stops, and the sample loading module samples the sample in the module and adds the reagent strip addition port to start the immunochromatographic reaction;

Step 3: The reaction tray continues to rotate, the reagent strip in the first position leaves the sample application area, and the reagent strips in the subsequent position enter the sample application area successively, and are successively paused to complete the sample loading;

Step 4: The reaction tray continues to rotate, the first position reagent strip is rotated to the detection module, and the detection device completes the detection of the reagent strip at the first position, and sends the result to the computer for processing.

The loading step includes the following two cases:

A sample does not need to be diluted: the sample loading device first picks up the disposable tip, then moves to the sample area to take the sample, then moves to the reaction plate area to complete the sample loading process, and then the sample loading device moves to the disposable tip collection box recovery port. Remove the disposable tip and perform a new round of loading;

B sample needs to be diluted: the sample loading device first picks up the disposable tip, and the sample area of the movement absorbs the sample, then moves to the dilution tank to add the sample to the dilution tank, and then sucks the diluent into the sample, and repeatedly draws and samples the sample. After dilution, move to the reaction plate loading area to complete the sample loading, then carry out the disposable tip recovery, and then pick up the new tip for a new round of loading after moving to the disposable tip box.

A plurality of samples can be discharged in the sample module.

The beneficial effects of the invention:

The invention solves the problem that the in vitro diagnostic product is difficult to realize automation by providing a fully automatic fluorescent immunological quantitative analysis device, avoids cross-contamination by the disposable aspirating device, and has precise reaction time control, and improves the repeatability and accurate test of the instrument. Degree, the automatic test of the rapid diagnostic instrument is realized, the human error is reduced, the precision of the test is improved, and the detection efficiency is improved.

The invention can realize detection of a plurality of samples together. The invention is applicable to both direct sample detection and dilution sample detection.

The invention adds a drying hole in the reagent strip storage box, can ensure the drying of the reagent strip and improve the detection accuracy.

The invention comprises a liquid path washing system capable of ensuring that the disposable tip picker is cleaned so that the sucked sample is not contaminated.

DRAWINGS

Fig. 1 Schematic diagram of the control system structure of the automatic fluorescent immunoassay device.

Figure 2 is a perspective view of a fully automated fluorescent immunoassay device.

Figure 3 is a top view of the fully automated fluorescent immunoassay device.

Figure 4 is a schematic diagram of the structure of the stent of the automatic fluorescent immunoassay analyzer.

Figure 5 shows the structure of the sample module.

Figure 6 is a schematic diagram of the structure of the reaction disk module.

Figure 7 shows the storage structure of the reaction plate without reagent strips.

Figure 8 is a schematic diagram of the structure of the reagent strip storage, that is, the automatic loading module.

Figure 9 is a schematic view showing the structure of the reagent strip storage case and the holder assembly.

Figure 10 is a schematic view showing the external structure of the reagent strip storage case.

Figure 11 is a schematic view showing the internal structure of the reagent strip storage case.

Figure 12 is a schematic view showing the structure of the automatic ejection device of the reagent strip storage box.

Figure 13 is a schematic flow chart of the method of automatic fluorescent immunoassay.

In the figure: 1 is the support bottom plate, 2 is the circuit box, 3 is the reagent strip storage and automatic loading module, 4 is the reaction disk module, 5 is the detection module, 6 is the sample module, 7 is the sample loading module, 8 is the washing module, 9 is the X arm, 10 is the Y arm, 11 is the Z arm, 12 is the disposable tip picker, 13 is the stepper motor assembly, 14 is the pulley, 15 is the slide rail, 16 is the fixed plug, 17 is the disposable suction The head box, 18 is a mixing box, 19 is a diluent tank, 20 is a sample unit, 21 is a head collection box, 22 is a track, 23 is a platform, 24 is a recovery port, 25 is a rack, and 26 is a reagent strip slot. 27 is the reagent strip outlet, 28 is the reagent strip slot notch, 29 is the first motor, 30 is the first synchronous wheel, 31 is the first synchronous belt, 32 is the reagent strip storage box, 33 is the storage box bracket, 34 is Buckle lock, 35 is the second motor, 36 is the second synchronous wheel, 37 is the second timing belt, 38 is the elastic hanging rod, 39 optical detecting device, 40 is the front box plate, 41 is the needle washing tank, 42 is the syringe pump 43 is a liquid washing bottle, 44 is a waste liquid bottle, 45 is an automatic loading component, 46 is a reagent strip descending rail, 47 is a notch, 48 is a sealing elastic piece, and 49 is a desiccant jack. Sensor 50, the reagent strip 51 tracks.

detailed description

The automatic fluorescent quantitative analysis device and the detection method thereof of the present invention are detailed in the following with reference to the accompanying drawings. instruction of.

Example 1

As shown in Figures 2, 3 and 4, a fully automatic fluorescent immunoassay device includes a support base plate 1 and a control system, and further includes a reagent strip storage and automatic loading module 3 and a reaction disk module 4 arranged in sequence on the bottom plate. The detection module 5, the sample module 6, the loading module 7 and the washing module 8; the reagent strip storage and automatic loading device 3 provides a reagent strip for the reaction disk module 4, and the loading module 7 adds the sample in the sample module 6 to the reaction disk module. The reaction is carried out on the reagent strip of 4, and after completion of the reaction, it enters the detection module 5 to complete the detection.

As shown in Figures 2 and 4, the loading module 7 includes an XYZ moving robot arm and a disposable tip picker 12; the X arm 9 is horizontally disposed at the top of the circuit box 2, and the Y arm 10 is located in the sample module 6. The upper portion is vertically connected to the X arm 9, and the Y arm 10 is slidable on the X arm 9. The Z arm 11 is vertically fixed in the sliding groove of the Y arm 10, and can be slid back and forth along the Y arm 10. A disposable tip pickup 12 is attached to the bottom of the Z-arm 11. The stepping motor assembly 13 is connected to the XYZ arm, and the stepping motor assembly 13 is controlled by the system to control the sliding of the Y and Z arms, so that the disposable tip picker 12 can be up and down in the sample module 6 and the reaction panel module 4 area. mobile. The circuit box 2 includes various control devices such as a line and a main control board.

As shown in FIG. 5, the sample module 6 is a drawer-like device, and has baffles on the left and right sides. The outer side of the baffle has a pulley 14, which can slide back and forth along the outer slide rail 15, and a fixed latch 16 is arranged at the front end of the baffle. The drawer can be fixed; the module includes a disposable tip box unit 17, a mixing box 18, a diluent tank 19, a sample unit 20 and a tip collection box 21; the sample unit 20 is located on the bottom plate of the drawer and passes through the bottom plate. The track 22 is fixed and can be slid forward and backward; the drawer is provided with a platform 23, and the lower portion thereof is separated, and the suction head recovery box 21, the disposable tip box 17 and the mixing box 18 are sequentially discharged on the platform 23, and the suction is performed. A portion of the head recovery box 21 passes through the platform 23 on the platform 23, and a portion is under the platform 23. The top end of the suction head recovery box 21 is provided with a recovery port 24, and the bottom end is empty. The suction head enters the recovery port 24 and directly falls onto the bottom plate. The disposable tip box 17 and the mixing box 18 are supported by the frame of the holder 25. The diluent tank 19 is located between the sample unit 20 and the platform 23, and also has a bottom rail 22 fixed to the bottom plate.

As shown in FIG. 6, the reaction disk module 4 is a disk-shaped device, and 16-20 reagent strip slots 26 are fixed at the edge of the disk, wherein the slot port and the reagent strip storage and automatic loading module 3 The reagent strip outlet 27 corresponds to the position, and the reagent strip storage and autoloading module 3 can push the reagent strip into the reagent strip slot 26; the lower portion of the reaction disc module 4 is connected to the first motor 29 via the bottom plate and the bottom plate bottom, and the first motor 29 is connected The control system is connected, and the control system drives the first synchronous wheel 30 and the first synchronous belt 31 by regulating the first motor 29. Finally, the rotation of the reaction disk is controlled.

As shown in FIGS. 3 and 6, the detecting module 5 is located between the reagent strip storage and automatic loading device 3 and the circuit box 2, and has an immunofluorescence detecting device 39 thereon, and the reagent strip in the reaction tray is rotated to the detecting device to complete Fluorescence detection.

As shown in Figures 2, 3 and 4, the circuit box 2 is fixed to the bottom plate 1, and includes a box top, a front box 40, a rear box and a side box; wherein the front box has a washing slot 41 The tank has a conduit connected to the waste liquid bottle 44 and the liquid washing bottle 43 located outside the side tank plate; the front tank plate also has a syringe pump 42 connected to the disposable tip picker 12.

The device of the invention also passes corresponding information through an output module, such as an external computer, a printer, a touch display

As shown in FIG. 1 , the automatic fluorescent immunoassay device control system comprises a power interface (P1), a main control board, a touch display screen, an external interface (P10), an RFID module, a scanner module, a printer module, Photocell signal input, motor driver group, motor, auto-loading module, infrared sensor and other sensors; the power supply interface is filtered by the mains via the power supply filter, and then converted to 24V DC power supply by the switching power supply to the main control board. And related modules. The main control board is the instrument control center, which loads the main control program, collects the sensor information of each channel, accepts the operation request through each input interface, and controls the operation test of the instrument according to the output control command pre-programmed according to the software system and method documentation, and manages the state of the instrument. And output the corresponding information to an external computer, printer, touch display through the output device; the automatic sample loading module operates on the pump and the mechanical arm of the liquid path system according to the instruction of the main control board; the photocell and other sensors provide the necessary information for the instrument; The external interface board provides an interface to connect to an external computer and an external bar code scanner to input and output information.

In this embodiment, the working principle of the fully automatic fluorescent immunoassay analyzer is as follows:

The automatic fluorescent immunoassay analyzer moves to the sample module 6 through the XYZ moving robot arm of the loading module 7, and picks up the disposable tip in the disposable tip box 17 through the disposable tip picker 12 of the Z arm 11 Moving to the top of the sample unit 20, the Z-arm 11 moves up and down, and the syringe pump 42 sucks the sample in the sample tube through the disposable tip. After the suction is completed, the instrument selects whether to perform dilution according to different test items, and if not diluted, the XYZ motion The mechanical arm directly sends the disposable tip to the reagent strip at the position of the reagent strip slot 26, and the loaded reagent strip completes the reaction on the reaction tray. After the reaction is completed, the reagent strip is rotated to the detection module 5, The detection is completed by the optical detecting device 39, and then the reagent The strip is pushed out of the instrument; if the sample needs to be diluted, the XYZ moving robot raises the sample sucked by the disposable tip into the diluent tank 19, and simultaneously fills the diluent tank 19 by drawing an appropriate amount of the diluent. The syringe pump 42 repeatedly sucks and draws the sample and the diluent is thoroughly mixed. After fully mixing, the XYZ moving robot arm sends the disposable tip to the reagent strip at the position of the reaction strip reagent strip slot 26, and the loaded reagent strip is The reaction is completed on the reaction disk. After the reaction is completed, the reagent strip is rotated to the detection module 5, and the detection is completed by the optical detection device 39, and then the reagent strip is pushed out of the instrument.

After the sample loading is completed, the disposable tip picker 12 is moved to the needle washing tank 41, and the washing liquid bottle 44 washes the disposable tip picker 12, and the waste liquid flows into the waste liquid bottle 43 through the pipe.

Example 2

A fully automatic fluorescent immunoassay analyzer, the reagent strip storage and automatic loading module 3 and the associated reaction disk module 4 have the following specific structures, and other module configurations are similar to those of the first embodiment.

As shown in FIG. 6, the reaction disk module 4 is a disk-shaped device, and a plurality of reagent strip slots 26 are fixed at the edge of the disk, wherein the slot mouth and the reagent strip outlet 27 correspond to each other, as shown in FIG. 7. As shown, there is a notch 28 in the middle of the lower surface of the reagent strip slot 26, the notch 28 allows the elastic hanger 38 to feed the reagent strip into the reagent strip slot 26; the lower portion of the reaction tray module 4 passes through the bottom plate and the bottom motor. 29 is connected, the first motor 29 is connected to the control system, and the control system controls the first motor 29 to drive the first synchronous wheel 30 and the first timing belt 31 to finally control the rotation of the reaction disk.

As shown in FIGS. 8 and 9, the reagent strip storage and automatic loading module 3 includes a reagent strip storage box 32, a storage box holder 33 and an automatic loading unit 45. The storage box holder 33 is fixed on the support base plate 1, and the reagent strip is stored. The case 32 is fixed to the bracket by a latch 34. The automatic loading assembly 45 is composed of a second motor 35, a second synchronous wheel 36, a second timing belt 37, and a flexible hanger 38. The control system controls the second motor 35 to operate, drives the second synchronous wheel 36, the second timing belt 37, and the elastic hanging rod 38 to move, hooks the reagent strip at the bottom of the reagent strip storage box 32, and sends the reagent strip to the reagent strip of the reaction tray. In slot 26. As shown in Fig. 12, the elastic hanger 38 is a rod located below the reaction tray reagent strip slot 26 and reciprocates along the line of the slot below the reaction tray and storage case. The front end of the elastic hanging rod 38 has a resilient hook with a pressing force. When working, it enters under the reagent strip, and the hook is pressed down by the reagent strip until it enters the groove below the reagent strip to recover. The movement moves back from the storage box to the reagent strip slot of the reaction tray, and the hook is re-entered when exiting. Press down to exit the reagent strip groove.

The reagent strip storage box 32 includes a box body and a lid portion, and the box body and the lid are fixed by slots, screws, and the like. The method is sealed; the reagent strip storage box 32 has a reagent strip descending guide 46; the reagent strip storage box 32 has a notch 47 at the bottom; the reagent strip storage box 32 has a sealing elastic piece 48 near the bottom end of the notch 47; the reagent strip storage box 32 A desiccant hub 49 for the desiccant is placed on the surrounding wall.

As shown in FIG. 10, the notch 47 extends from the bottom end side of the reagent strip storage case 32 to the other side, and may extend from a notch corresponding to the reagent strip to the other side of the bottom end. The sealing shrapnel 48 can only be bounced externally to the reagent strip storage case 32.

As shown in FIG. 11, the reagent strip descending rail 46 may be a rail that abuts the inner wall of the reagent strip storage box 32, or may be a rail that is suspended from the top, and the reagent strip descending rail 46 is away from the reagent strip storage box. The distance between the bottom ends of 32 is between 1-2 strip thicknesses.

As shown in Figure 8, there is a sensor 50 on the bracket assembly 33 through which the number of remaining reagent strips is counted.

In the automatic fluorescent immunoassay analyzer of the present embodiment, there are three reagent strip storage and automatic loading modules 3, and three reagent strips are loaded each time. There are 16 reaction plate reagent strip slots 26. The sample loading module 7 adds the sample to the reagent strip in the Nth reaction disk slot, and the detection module 5 detects the reagent strip in the N+13 position reagent strip slot. After the test is completed, the reaction plate position without the reagent strip is rotated to the automatic loading area, and the reagent strip is automatically loaded into the reaction tray through the elastic hook to start a new cycle.

In this embodiment, the reagent strip loading process is as follows:

The reagent strip is placed in the reagent strip storage box 32. In order to prevent the measurement result from being wet due to the wetness of the reagent strip in the reagent strip storage case 32, the desiccant is placed in the desiccant insertion hole 49 of the reagent strip storage box 32, and the plug is inserted. The tank, the screw, and the like are fixed to seal the reagent strip storage case 32.

The reagent strip storage box 32 storing the reagent strip is placed in the slot of the bracket assembly, and the reagent cartridge fixing buckle 34 is fastened to fix the reagent strip storage box 32.

By rotating the second motor 35 of the automatic ejecting device, the second synchronizing wheel 36 on the second motor 35 drives the second timing belt 37, thereby driving the elastic hanger 38, the elastic hook 38 at the bottom notch 47 of the reagent strip storage case 32 and The reagent strip track 51 shown in Fig. 11 moves linearly, and the reagent strip is pulled out from the reagent strip storage case 32 by the sealing elastic piece 48, and the number of remaining reagent strips is counted by the sensor 50.

The reagent strip in the reagent strip storage box 32 can only move along the guide rail due to the action of the reagent strip lowering guide rail 46, and falls from the top of the reagent strip storage box 32 to the bottom under the action of gravity, thereby realizing automatic loading of the reagent strip.

Example 3

A fully automatic fluorescent immunological quantitative analysis device, the detection module 5 is provided with an elastic hook, and other module configurations are similar to those of the second embodiment.

After the detection module 5 completes the detection of the reagent strip, the elastic hook under the detection module 5 pushes the reagent strip out of the reaction tray and enters below the detection device. After the next reagent strip has been tested, the previous reagent strip is pushed out of the device of the present embodiment by the next reagent strip, and the next reagent strip remains below the detection device.

Example 4

As shown in FIG. 13, the present invention discloses a fully automatic fluorescent immunological quantitative analysis method, which comprises the following steps:

Step 1) reagent strip storage and automatic loading module loading reagent strip into the reagent strip slot in the reaction tray;

Step 2) The reaction tray starts to rotate, and the reagent strip in the first position enters the sample loading area with the rotation, and the sample loading module sucks the sample in the module to add the reagent strip addition port to start the immunochromatographic reaction;

Step 3) the reaction tray continues to rotate, the reagent strip in the first position leaves the sample application area, and the reagent strips in the subsequent position enter the sample application area one after another, and are successively paused to complete the sample loading;

Step 4) The reaction tray continues to rotate, and the detection module of the first position of the reagent strip rotates, and the detection device completes the detection of the reagent strip at the first position, and sends the result to the computer for processing.

In the above method, the reagent strip loading method is to hook the reagent strip from the reagent strip storage box by the elastic hook of the elastic hook of the loading device.

In the analysis method of the present invention, the loading step includes the following two cases:

In the analysis method of the present invention, a plurality of samples can be discharged in the sample module, which is not limited in the present invention.

In the analysis method of the present invention, after the detecting device detects the reagent strip, the elastic hanging under the detecting device The hook pushes the reagent strip out of the reaction tray and enters below the detection device. After the next reagent strip is tested, the previous reagent strip is pushed out of the device by the next reagent strip, and the next reagent strip is left under the detection device. After the detection is completed, the reaction disk position without the reagent strip is rotated to the automatic loading area, and the reagent strip is automatically loaded into the reaction disk through the elastic hook to start a new cycle.

Claims

The utility model relates to a full-automatic fluorescence immunological quantitative analysis device, which comprises a supporting bottom plate (1), a reagent strip storage and automatic loading module (3), a reaction disk module (4), a detecting module (5) and a sample module (6). , sample loading module (7), washing module (8) and control system, the reagent strip storage and automatic loading module (3), reaction disk module (4), detection module (5), sample module (6), plus The sample module (7) and the washing module (8) are sequentially arranged on the support bottom plate (1), and the reagent strip storage and automatic loading module (3) provides a reagent strip for the reaction disk module (4), and the sample loading module (7) The sample in the sample module (6) is added to the reaction disk module (4) for reaction, and after completion of the reaction, the detection module (5) is completed to complete the detection.
The immunological quantitative analysis device according to claim 1, wherein the loading module (7) comprises an XYZ moving robot arm, a disposable tip picker (12) and a syringe pump (42); and an XYZ motion machine. The arm includes an X arm (9), a Y arm (10) and a Z arm (11), the X arm (9) is horizontally arranged along the sample module (6) and the reaction disk module (4); the Y arm (10) is located in the sample module ( 6) The upper part is perpendicularly connected to the X arm (9) and slides on the X arm; the Z arm (11) is vertically fixed in the sliding groove of the Y arm (10), and the disposable tip picker is mounted on the bottom of the Z arm (11). (12) The syringe pump (42) is coupled to the disposable tip picker (12) to provide sampling power to the disposable tip picker (12).
The quantitative analysis device according to claim 1, wherein the sample module (6) comprises a disposable tip box (17), a mixing box (18), a diluent tank (19), and a sample unit (20). a suction head recovery cartridge (21) and a sample module cartridge, the sample unit (20) and the diluent tank (19) are located on the bottom plate of the sample module box, and the bottom plate is provided with a rail (22), a sample unit (20) and The bottom of the dilution tank (19) is provided with a card slot matched with the rail (22), and the sample unit (20) and the diluent tank (19) slide back and forth on the floor rail (22); a platform (23) is arranged on one side of the sample module box. The lower part of the platform (23) is separated, and the suction head recovery box (21), the disposable suction head box (17) and the mixing box (18) are discharged on the platform (23), and the suction head recycling box (21) portion Through the platform (23) on the platform (23), part of the space in the lower part of the platform (23), the top of the suction box is provided with a recovery port (24), the bottom end is not sealed, and the tip enters the recovery port and falls directly into the On the bottom plate.
The quantitative analysis device according to claim 3, wherein the sample module box is arranged in a drawer shape, and the left and right sides have a baffle, and the outer side of the baffle has a pulley (14), and the slide rail (15) along the outer side Slide up and down, the front end of the baffle has a fixed latch (16) for fixing the drawer.
The quantitative analysis device according to claim 1, wherein the reaction disk module (4) is a disk-shaped device, the disk edge fixing reagent strip slot (26), the slot opening and the reagent strip storage And automatic The reagent strip (27) of the loading module (3) corresponds to the position of the reagent outlet (27), and the reagent strip is loaded; the reaction tray brings the reagent strip to the position corresponding to the loading module (7) to complete the sample loading operation; the reaction tray brings the reagent strip to the detection module. (5) The corresponding position completes the detection operation.
The quantitative analysis device according to claim 5, wherein the reaction disk is connected to a first motor (29), and the first motor (29) drives the first synchronous wheel (30) and the first timing belt (31). Driving the reaction disk to rotate; the reaction plate reagent strip slot (26) is 2N or 2N+1, N≥1.
The quantitative analysis device according to claim 1, wherein the reagent strip storage and automatic loading module (3) comprises a reagent strip storage box (32), a storage box holder (33), and an automatic loading assembly (45). The storage box bracket (33) is fixed on the support base plate (1), the reagent strip storage box (32) is fixed on the storage box bracket (33) by the buckle lock (34); the automatic loading assembly (45) is driven by the second motor (35) The second synchronous wheel (36), the second synchronous belt (37) and the elastic hanging rod (38), the control system controls the second motor (35) to operate, and drives the second synchronous wheel (36) and the second synchronous belt (37), the elastic hanging rod (38) moves; the reaction plate module (4) is provided with a reagent strip slot (26), and a gap (28) is formed in the middle of the lower bottom surface, and the notch (28) can be elastically hung The rod (38) sends the reagent strip into the reagent strip slot (26).
The quantitative analysis device according to claim 7, wherein the reagent strip storage case (32) comprises a case body and a cover portion, the case body and the cover are sealed; and the reagent strip storage case (32) has a reagent strip therein. a descending guide rail (46); a bottom of the reagent strip storage box (32) has a notch (47), and a side of the reagent strip storage box (32) adjacent to the bottom end of the notch (47) has a sealing elastic piece (48); There are 1-3 reagent strip storage and automatic loading device modules (3).
The quantitative analysis device according to claim 1, characterized in that the washing module (8) comprises a needle washing tank (41), a waste liquid bottle (44), a liquid washing bottle (43), a needle washing tank (41) The inner tube is connected to the waste liquid bottle (44) and the liquid washing bottle (43).
A method for detecting a fully automatic fluorescent immunoassay device according to claim 1, comprising the steps of:

Step 1: The reagent strip storage and automatic loading module loads the reagent strip into the reagent strip slot in the reaction tray;

Step 2: The reaction tray starts to rotate, and the reagent strip in the first position enters the sample loading area and stops, and the sample loading module samples the sample in the module and adds the reagent strip addition port to start the immunochromatographic reaction;

Step 3: The reaction tray continues to rotate, the reagent strip in the first position leaves the sample application area, and the reagent strips in the subsequent position enter the sample application area successively, and are successively paused to complete the sample loading;

Step 4: The reaction tray continues to rotate, and the detection module of the first position of the reagent strip rotates, and the detection device completes the detection of the reagent strip at the first position, and sends the result to the computer for processing.
The detecting method according to claim 10, wherein the loading step is any one of the following two cases:

A sample does not need to be diluted: the sample loading device first picks up the disposable tip, then moves to the sample area to take the sample, then moves to the reaction plate area to complete the sample loading process, and then the sample loading device moves to the disposable tip collection box recovery port. Remove the disposable tip and perform a new round of loading;

B sample needs to be diluted: the sample loading device first picks up the disposable tip, and the sample area of the movement absorbs the sample, then moves to the dilution tank to add the sample to the dilution tank, and then sucks the diluent into the sample, and repeatedly draws and samples the sample. After dilution, move to the reaction plate loading area to complete the sample loading, then carry out the disposable tip recovery, and then pick up the new tip for a new round of loading after moving to the disposable tip box.